Lee Ann Storey Rn, Mph Email & Phone Number

Tarrytown, New York, Us

• Led Good Pharmacovigilance Practice (GVP) qualification and routine vendor audits (e.g., specialty pharmacy, market research program, patient support program, safety case processing), sent and followed-up on distributor surveys, and led internal process audits (e.g., safety case processing, labelling development and maintenance, aggregate report writing, signal detection, safety data exchange agreement, and adverse event and product technical complaint reconciliation).• Collaborated within QAA, with vendors, and with Business Owners/Functional Area Leads to facilitate audit closure (e.g., followed-up on auditee response to audit findings within designated timeframes, reviewed/discussed/consulted on audit responses with vendor and interdepartmentally).• Collaborated internally and with vendors to guide, discuss, and obtain documentation of actions taken for corrective action/ preventive action related to major observation(s). Reviewed, during follow-up audits, actions taken by auditee in response to minor observations noted in prior audit. • Contributed within QAA to maintaining/extending the GVP audit universe, conducting benefit/risk analysis, and from analysis results developing the annual pharmacovigilance audit schedule. • Assisted in selection and hiring of QAA GVP auditors, as well as selection and onboarding of contract auditors.• Trained new audit team members and contract auditors. • Provided oversight to ensure audits were performed appropriately. • Participated on cross-functional teams such as the audit database development team to facilitate database development and database compliance with related regulations and internal procedures.• Independently identified training opportunities for staff members such as search techniques to assist auditors in conducting data analysis of safety case line listings, and group review of audit findings for development and consistency in classification of audit observations.

Tarrytown, New York, Us

• Conducted the job functions of the Associate Manager QA Auditor • Developed and supported GVP strategy (Strategic Audit Plan, Tactical Annual Plan, Individual Audit Plan). • Developed and maintained QAA Standard Operating Procedures and Work Instructions.• Contributed to QAA process revisions (Marketing Authorization Holder European pharmacovigilance requirements).• Led the identification of internal quality/compliance issues and acted as a catalyst for process improvements to promote standardization and best practices within QAA and across Regeneron.• Identified and informed relevant departments about possible improvements in safety sections within contracts and safety data exchange agreements. This resulted in additional drug safety reviewers for contracts and enhanced text within safety sections

Tarrytown, New York, Us

• Conducted the job functions of the Senior Auditor GVP Audits• Led GVP process and vendor audits. • Supported GVP and GCP development and execution of risk-based audit plans.

Tarrytown, New York, Us

• Scheduled, prepared, and conducted audits in support of GVP QAA, and in accordance with Regeneron standard operating procedures and quality policies.• Reported findings to management with recommendations for resolution and verified appropriate Regeneron Pharmaceuticals, Inc., Tarrytown, NYSenior QA Auditor (GVP), Quality Assurance and Auditing (QAA)• Scheduled, prepared, and conducted audits in support of GVP QAA, and in accordance with Regeneron standard operating procedures and quality policies.• Reported findings to management with recommendations for resolution and verified appropriate corrective actions had been implemented and documented.• Represented QAA on teams, compliance projects and initiatives both within and across functional areas of Regulatory Affairs, Pharmacovigilance, and Global Development, as assigned.• Interpreted policies, standards, and regulations, and evaluated potentially critical problems not covered by policies, standards, and regulations.• Exercised judgment in ensuring written procedures were followed when evaluating quality systems, processes, procedures, and protocols for compliance.• Appropriately escalated compliance issues.

Stamford, Ct, Us

Director Product Monitoring 2004- April 28, 2017• Formulated and executed practices and procedures for the capture, processing, and maintenance of Adverse Events (AEs) and Product Technical Complaints (PTCs), and for the providing of Medical and Quality information to assure patient safety and minimize company liability. • Led development team with IT develop group and ran scripts to validate AE/PTC Call Center database (front end) and PTC Database. • Received and processed AEs and PTCs; Data entered information into the telephone and AE database; Generated Form FDA 3500As and Council for International Organizations of Medical Sciences (CIOMS) Forms. • Collaborated/Contracted with a vendor and trained vendor staff to answer calls to the Safety call center line and to process AE and PTC reports for Company product. The vendor assisted the Product Monitoring Group when cases exceeded an internal case threshold for internal call center and case processing resources. Provided vendor oversight and led vendor/Company meetings to review communications, metrics, case handling and resource needs. • Contributed to product quality investigations by reviewing, stability data, certificates of analysis, equipment calibration logs, and manufacturing logs.• Enhanced regulatory transparency and FDA/ICH and EU regulatory compliance by providing upper management critical data and evaluation and by responding to client inquiries. • Drove process improvement by leading cross-functional teams for identification and implementation of lean activities (global AE/PTC reporting; call center functions, global database) and for transparency of group functions (i.e., Medical Affairs, GVP, and Customer Service). • Enhanced team quality as Business Owner of Electronic Product Complaints Application, Source Application, and Telephone Database for AEs and PTCs by directing team toward successful application.

Stamford, Ct, Us

• Fulfilled company regulatory responsibility for post-market surveillance by writing/reviewing and submitting SAEs and PSURs• Formulated and executed practices and procedures for the capture and processing of Adverse Events to assure patient safety and minimize company liability.• Conducted audit of individual patient assistance program to evaluate accuracy and implement a process to correctly categorize Adverse Events.Key accomplishments:• Developed process for ensuring that all adverse events due to death were accurately captured and reported to regulatory agencies.• Created global Adverse Event database accessible by worldwide Purdue safety staff and upper management to accurately tract and report Adverse Events in accordance with local regulatory requirements.• Minimized company liability by formulating/ executing practices and procedures for capturing and processing Adverse Events and Product Complaints, ensuring greater patient safety.

Stamford, Ct, Us

Assistant Director Drug Regulatory Affairs 9/92-8/99• Formulated and executed practices and procedures to develop and support labeling initiatives in compliance with Company and local regulatory requirements. • Enhanced Company communication by facilitating domestic and international projects relative to product labeling, development, and discussion of ad hoc issues (e.g., safety trends, regulatory request for labeling changes).• Collaborated on cross functional teams to align product labeling with the CCDS and local health authority's regulations and guidelines. Provided US specific labeling feedback.• Provided labeling documents needed for regulatory submissions to the FDA (i.e., NDA, NDA Annual Reports, Periodic Adverse Drug Experience Reports).• Provided training and supported staff in labeling process and initiatives to develop expertise and transparency.

Bachelor'S Degree, Registered Nursing

Masters Deree, Public Health